510(k) K011270 ยท FCG Biopsy Needle
AUTOMATED CORE BIOPSY DEVICE
| Applicant | Promex, Inc., Franklin IN, US |
| Decision | Substantially Equivalent, Jun 22, 2001 |
| Received | Apr 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011270
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.